Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.

An Indian drugmaker has halted production of a couple of APIs after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu,…

Jazz Pharmaceuticals has released new vials of Erwinaze, its leukemia drug for children, that came into short supply in 2016.

Regeneron's Eylea has been a hit on the market for years. But now, the number of patients experiencing a rare side effect is climbing.

After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.

The FDA has issued a warning letter to a Bayer finished products plant in Germany, where it says poor cleaning led to product cross-contamination.

The EMA has been probing the safety of Allergan’s Esmya since December. Now it's advising no new patients start taking it until the investigation wraps up.

AmerisourceBergen has received a grand jury subpoena to supply info to the DOJ about its testing of a syringe made at its PharMEDium lab in Tennessee.